Prehospital Tranexamic Acid for Severe Trauma
Primary result · Survival with a favorable functional outcome (GOS-E level ≥5)Result — go to the resultRR of survival with a favorable functional outcome 1.00 95% CI 0.90–1.12Authors' conclusion
Among adults with major trauma and suspected trauma-induced coagulopathy who were being treated in advanced trauma systems, prehospital administration of tranexamic acid followed by an infusion over 8 hours did not result in a greater number of patients surviving with a favorable functional outcome at 6 months than placebo.
Study context
- Population
- Adults with major trauma at risk for trauma-induced coagulopathy, treated by EMS in advanced trauma systems (Australia, New Zealand, Germany)assignment unknown for 3
- Participants
- 1,310 adults
- Comparison
- Prehospital TXA vs matched placebo
- Tranexamic acidn = 661
- Placebon = 646reference
- Primary endpoint
- Survival with a favorable functional outcome:
- Glasgow Outcome Scale-Extended (GOS-E) level ≥5
- GOS-E range 1 [death] to 8
- Follow-up
- 6 months after injury
Methodological detailsplacebo-controlled, multicentre, 15 EMS in Australia, New Zealand, and Germany
- Placebo-controlled
- Multicentre
- 15 EMS in Australia, New Zealand, and Germany
Primary result
As reported in the abstract
Survival with a favorable functional outcome (GOS-E level ≥5) · 6 months
RR of survival with a favorable functional outcome
1.00
95% CI 0.90–1.12
P = 0.95
Events by treatment group
Tranexamic acid vs Placebo
RR of survival with a favorable functional outcome 1.00 (95% CI 0.90–1.12); P = 0.95
Secondary outcomes
| Outcome | Tranexamic acid | Placebo | RR (95% CI) | |
|---|---|---|---|---|
| Death from any cause · 28 days | 17.3% | 21.8% | 0.79 (0.63–0.99) | |
| Death from any cause · 6 months | 19.0% | 22.9% | 0.83 (0.67–1.03) | |
| 0.512Relative risk (log scale) |
- Death from any cause: 113 of 653 vs 139 of 637
- Death from any cause: 123 of 648 vs 144 of 629
Safety
Serious adverse events, including vascular occlusive events
- Did not differ meaningfully between the groups
Original publication
Prehospital Tranexamic Acid for Severe Trauma. N Engl J Med. Published 14 June 2023. doi:10.
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